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Aqueous Cream Bp

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Aqueous Cream BP

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Emulsifying Ointment BP    30% w/w

White soft paraffin    15% w/w

Liquid paraffin    6.0%    w/w

Cetostearyl alcohol    8.1% w/w

This product contains sodium lauryl sulfate 0.9% w/w, see section 4.4. This product contains cetostearyl alcohol, see section 4.4

For the full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Cream (Topical Semisolid)

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For topical application to the skin:

As an emollient for the symptomatic relief of dry skin conditions As a soap-substitute for skin washing.

4.2    Posology and method of administration

Adults, children and the elderly

To be applied to the skin as required

4.3    Contraindications

None

4.4 Special warnings and precautions for use

For external use only.

Paediatric _ population

Aqueous cream contains sodium lauryl sulfate which may cause local skin reactions (e.g. stinging and contact dermatitis), particularly in children with atopic eczema.

An audit of children attending a paediatric dermatology clinic recorded the proportion of immediate cutaneous reactions to emollients (defined as one or more of burning, stinging, itching and redness developing within 20 minutes of application). Aqueous cream was the emollient used by most (71%), which was associated with an immediate cutaneous reaction in 56% of exposures, compared with 18% with other emollients used (details of the other emollients were not reported; n = 100).

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Fertility, pregnancy and lactation

Can be used during pregnancy and lactation

4.7 Effects on ability to drive and use machines

None known

Undesirable effects

4.8


Aqueous cream may be associated with immediate cutaneous reactions when used as a leave-on emollient, such as stinging, burning, itching and redness. See section 4.4

4.9 Overdose

If accidentally ingested, treat smptomatically.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

The emulsifying ointment, in an aqueous mixture, produces a non-greasy cream which is used to protect skin against dirt and grease and has a detergent effect as a skin cleanser

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

None stated

6.1 List of excipients

Emulsifying ointment (contains emulsifying wax, which itself contains cetostearyl alcohol and sodium lauryl sulfate).

Liquid paraffin

White soft paraffin

Phenoxyethanol

Purified water

6.2    Incompatibilities

None known

6.3    Shelf life

Unopened    24 Months

Opened    3    Months

6.4    Special precautions for storage

Store below 25oC.

Do not freeze.

6.5    Nature and contents of container

Plastic jar with tight lid

50g

Plastic jar with tight lid

100g

Plastic jar with tight lid

250g

Plastic jar with tight lid

500g

Plastic jar with tight lid

4000g

Plastic tube with cap

100g

6.6


Special precautions for disposal and other handling

As stated on label.

7    MARKETING AUTHORISATION HOLDER

Ayrton Saunders Ltd North Way

Walworth Industrial Estate

Andover

SP10 5AZ

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0177

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18/02/2009

10    DATE OF REVISION OF THE TEXT

09/07/2013